CompletedPhase 4

Cannabis and Tobacco Co-use Study

United States181 participantsStarted 2020-01-28

Plain-language summary

The purpose of this study is to better understand tobacco outcomes using a well-known stop smoking medication, varenicline, and financial incentives with tobacco users. The investigators are also interested in how cannabis/marijuana and tobacco interact during a tobacco quit attempt. All participants will receive tobacco cessation treatment (varenicline) for 12 weeks. This study will recruit adult tobacco users (ages 18-40) who are motivated to quit smoking cigarettes.

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Between the ages of 18 and 40 years old
. Must be able to understand the study and provide written informed consent
. Daily cigarette smoker for ≥ 6 months, smoking ≥ 5 cigarettes per day
. Must submit a breath carbon monoxide (CO) sample of ≥ 7 parts per million (ppm) at the screening visit
. Be interested in quitting smoking tobacco cigarettes (defined as a 5 or above on a 10-point Likert scale assessing interest in quitting \[1=not at all interested, 10=extremely interested\])
. Must be willing to take varenicline for the standard 12-week course of treatment
. If female, agreement to use birth control (any form) to avoid pregnancy during study procedures

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Biologically Verified 7-day Point Prevalence Tobacco Abstinence at the End of Treatment (Week 12)

Timeframe: Final 7 days of treatment (Week 12)

Trial details

NCT IDNCT04228965

SponsorMedical University of South Carolina

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-12

Results submitted2025-05-15

View on ClinicalTrials.gov More Tobacco Use Disorder trials

Plain-language summary

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Between the ages of 18 and 40 years old
. Must be able to understand the study and provide written informed consent
. Daily cigarette smoker for ≥ 6 months, smoking ≥ 5 cigarettes per day
. Must submit a breath carbon monoxide (CO) sample of ≥ 7 parts per million (ppm) at the screening visit
. Be interested in quitting smoking tobacco cigarettes (defined as a 5 or above on a 10-point Likert scale assessing interest in quitting \[1=not at all interested, 10=extremely interested\])
. Must be willing to take varenicline for the standard 12-week course of treatment
. If female, agreement to use birth control (any form) to avoid pregnancy during study procedures

Cannabis and Tobacco Co-use Study

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Cannabis and Tobacco Co-use Study

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria